Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity

Sponsor

Mahidol University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01501968

Collaborator

Siriraj Hospital (Other)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ascorbic acid (Vitamin C) could protect renal toxicity from colistin.

Condition or Disease	Intervention/Treatment	Phase
Drug Safety	Drug: Colistin Drug: Colistin + Ascorbic acid	Phase 3

Detailed Description

Renal toxicity due to colistin therapy is common. Ascorbic acid (vitamin C) has been shown to prevent colistin associated renal toxicity in animals. This study is conducted to determine if acorbic acid can prevent Colistin-Associated Nephrotoxicity.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Colistin Colistimethate sodium 2.5-5mg/kg iv	Drug: Colistin Colistimethate sodium 2.5-5mg/kg iv per day Other Names: Colistate
Experimental: Colistin + Ascorbic acid Colistimethate sodium 2.5-5mg/kg iv and ascorbic acid 2 grams iv every 12 hours	Drug: Colistin + Ascorbic acid Colistimethate sodium 2.5-5mg/kg iv per day and ascorbic acid 2 grams iv q 12 hours Other Names: vitamin c

Arm

Intervention/Treatment

Active Comparator: Colistin

Colistimethate sodium 2.5-5mg/kg iv

Drug: Colistin

Colistimethate sodium 2.5-5mg/kg iv per day

Other Names:

Colistate

Experimental: Colistin + Ascorbic acid

Colistimethate sodium 2.5-5mg/kg iv and ascorbic acid 2 grams iv every 12 hours

Drug: Colistin + Ascorbic acid

Colistimethate sodium 2.5-5mg/kg iv per day and ascorbic acid 2 grams iv q 12 hours

Other Names:

vitamin c

Outcome Measures

Primary Outcome Measures

number of patients with Renal toxicity associated with colistin [up to 28 days]
Renal toxicity associated with colistin according to RIFLE criteria

Secondary Outcome Measures

number of subjects with cure or improvement [up to 28 days]
cure improvement worse death

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age > 18 years hospitalized patient who needs colistin for therapy of nosocomial infection

Exclusion Criteria:

pregnant woman
lactating mother
allergy to ascorbic acid
receiving non-steroidal antiinflammatory drugs (NSAID), aminoglycosides, vancomycin, cisplatin, amphotericin-B
received radiocontrast media within 1 week
renal stone
G-6-PD deficiency